Quanticate UK - Head Office

  • Principal Medical Writer

    Job Locations IN-KA-Bangalore- | IN-Bangalore
    Posted Date 4 weeks ago(9/27/2018 9:20 AM)
    ID
    2018-1704
    # of Openings
    1
    Category
    Medical Writing
  • Overview

    We have an excellent opportunity for an experienced Medical Writer to join our Bangalore office.

     

    As a Principal Medical Writer you will assist the Head of Medical Writing in the provision of functional leadership and direction for the department. This position will also offer the successful applicant to work across a wide variety of projects and clients.

     

     

    Responsibilities

    • Provide expert advice and leadership on preparation and review of medical writing documents, as well as the processes and standards required, to both colleagues and clients
    • Produce well-written, high-quality, timely medical writing documents that conform with current Quanticate (or client-specific) SOPs and processes, as well as applicable regulatory requirements and/or guidelines
    • Ensure medical writing documents accurately reflect the data, source information, and any document-specific requirements, and review statistical outputs and source information as needed
    • Manage the document review process ensuring conflicting and/or ambiguous comments are clarified and adequately addressed
    • Review (including peer and QC review) medical writing documents in accordance with current SOPs, ensuring checklists and tracking documents are completed
    • Proof-read and provide editorial support on documents produced by other departments in Quanticate or by clients, if requested
    • Provide project management and oversight on medical writing projects and/or cross-functional projects using project management tools and processes
    • Independently plan, organise and prioritise workload to deliver multiple projects simultaneously within agreed timelines, while maintaining profitability
    • Collaborate effectively with project teams (including peer and QC reviewers) to ensure timely and efficient completion of projects
    • Using project management tools, drive and track project milestones and metrics
    • Complete and approve daily timesheets, providing and ensuring an accurate record of time spent on activities
    • Significantly contribute to best practice and process improvement by independently identifying opportunities/challenges and leading process improvement initiatives
    • Contribute to the development and implementation of medical writing standards, processes, guidelines and templates ensuring updates occur when and where appropriate
    • Interact directly with business development on requests received from clients; manage the process of collating and delivering requested information
    • Significantly contribute to business development by keeping CV up-to-date, preparing and reviewing client proposals and other business development documentation, as well as presenting at client meetings and bid defence meetings
    • Using professionalism, communicate directly with current and potential clients, and solicit feedback on client satisfaction if appropriate
    • Actively contribute to an environment of information sharing and communication within both Medical Writing and the Quanticate organisation
    • Provide training/mentorship to colleagues
    • Line manage assigned personnel taking an active role in their development, and provide guidance and mentorship to less experienced Medical Writers
    • Assist Head of Medical Writing with planning and implementation of recruitment strategies (as needed), and assess potential new recruits by evaluating writing tests and interviewing candidates

     

    Qualifications

    • Masters degree in a life science, science-related or medical subject (or equivalent experience)
    • PhD in a life science, science-related or medical subject preferable
    • Extensive experience preparing medical writing documents in the pharmaceutical industry, biotechnology or medical sector
    • Significant knowledge and experience on regulatory requirements and guidelines for scientific communications
    • Demonstrated ability to manage others
    • Published author of scientific literature desirable
    • Excellent written and verbal communication skills with the ability to convey complex concepts and information in a logical and concise manner
    • Excellent attention to detail
    • Excellent organisational skills with ability to manage priorities and work effectively and efficiently under pressure
    • Excellent analytical skills with a balanced approach to problem-solving, using flexibility and persistence as appropriate
    • Self motivated to work independently on projects
    • Assertive with good negotiation and influencing skills
    • Demonstrated judgement and decision-making skills
    • Dedicated team player with excellent interpersonal skills
    • Strong leadership skills
    • Proficient using Microsoft Office applications, version control, document management and reference management
    • Strong interest in continued self learning and educating others in the areas of science/medicine and medical writing topics/trends
    • Willingness to learn and be open to new ideas

     

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